Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

Phase 2

Terminated

• Conditions: Colitis, Ulcerative
• Interventions: Drug: STW5-II (Iberogast N, BAY98-7410); Drug: Placebo

• Registration Number: NCT02246686
• Lead Sponsor: Bayer

Brief Summary

The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-23
• Study Start: 2014-11
• Primary Completion: 2015-02
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
• Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
• Age between 18 to 80 years (including)
• UC may reach from left-sided colitis to pancolitis

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Exclusion Criteria

• Severe forms of UC (CAI > 10)
• Crohn's disease, infectious colitis or undetermined colitis
• Steroid dependence and steroid resistance
• Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
• Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
• Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
• Total colectomy
• Known allergies to components of STW5-II
• Severe allergic diathesis
• Topical mesalazine application
• Known intolerance to azo dyes E110 and E151

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STW5-II	STW5-II (Iberogast N, BAY98-7410)	Half of study population, assigned randomly
Placebo	Placebo	Half of study population, assigned randomly

Primary Outcome Measures

Name	Time	Method
Number of patients who reached a remission at least once during the course of the study	Week 12
Proportion of patients being in remission at final visit	Week 12	Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Change of endoscopic index (EI)	From baseline to week 12
Change of histological index (HI) based on Riley	From baseline to week 12
Proportion of patients reaching a clinical CAI ≤ 2 points	Week 12
Time to remission, defined as days from Day 0 until first remission is reached	Up to 12 weeks	Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached	Up to 12 weeks
Number of patients who reached a sustained remission at least once during the course of the study	Week 12
Change from baseline of absolute CAI values to final visit	From baseline to week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit	From baseline to week 12
Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit	From baseline to week 12
Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit	From baseline to week 12
Mayo Score throughout the study	Up to 12 weeks
Change of of oral mesalazine dose throughout the study period	From baseline to week 12
Change in ulcerative colitis (UC) markers	From baseline to week 12	Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients